44 558例患者梅毒螺旋体抗体检测及假阳性分析  

Analysis of antibody detection of Treponema pallidum and the false positive results of 44558 patients

作　　者：徐萌 绳波[1] 陈浩南[1] 崔红权 Xu Meng;Sheng Bo;Chen Haonan;Cui Hongquan(Department of Clinical Laboratory,Beijing Jiangong Hospital,Beijing 100054,China)

机构地区：[1]北京市健宫医院检验科,北京100054

出　　处：《中华实验和临床感染病杂志（电子版）》2021年第2期105-110,共6页Chinese Journal of Experimental and Clinical Infectious Diseases(Electronic Edition)

摘　　要：目的探讨门诊及住院患者梅毒螺旋体(TP)抗体检出情况,并对化学发光微粒子免疫分析法(CMIA)筛查的假阳性样本进行分析,评估CMIA在抗-TP检测中的应用价值。方法采用CMIA对2017年1月至2019年12月北京市健宫医院门诊及住院的44558例患者的临床标本进行TP特异性抗体筛查,TP抗体阳性样本进一步进行TP颗粒凝集试验(TPPA)确证和快速血浆反应素环状卡片试验(RPR)检测,应用SPSS 25.0软件对不同年龄和性别组间抗-TP筛查、RPR效价进行统计学分析。结果44558例血清样本经CMIA进行抗-TP筛查,检出抗-TP阳性样本996例。经TPPA确认阳性反应样本898例,CMIA初筛阳性与TPPA确认阳性结果比较,假阳性率为0.22%(98/44558),阳性预测值为90.16%(898/996),特异性为99.78%(43660/43758)。S/CO值大于9的样本,TPPA确证阳性预测值为100.00%(898/898),根据S/CO值分为1~2、2~3、3~5、5~9和>9共5组,TPPA阳性预测值差异有统计学意义(χ^(2)=309.81、P<0.001)。996例RPR试验样本中,检出RPR阳性336例,效价≤1︰8的样本占RPR阳性样本的84.23%(283/336)。≥80岁年龄组阳性率最高,经TPPA确认阳性反应样本阳性率为2.76%(84/3042),高于总体阳性率[2.02%(898/44558)],差异有统计学意义(χ^(2)=7.84、P=0.005)。TPPA确认阳性反应样本中男性患者阳性检出率为2.68%(467/17413),女性患者阳性率为1.59%(431/27145),差异有统计学意义(χ^(2)=64.31、P<0.001)。经RPR检测,40~59岁年龄组患者阳性率最高,为0.84%(124/14810),高于总体阳性率[0.75%(336/44558)]。经RPR检测男性患者阳性检出率为1.05%(182/17413),女性患者阳性检出率为0.57%(154/27145),差异有统计学意义(χ^(2)=32.37、P<0.001)。结论TP血清学试验采取CMIA联合TPPA和RPR检测的策略行之有效。重视对特殊人群、高危人群和重点科室抗-TP阳性结果的分析,正确检测、准确及时报告并合理解读TP血清试验结果极其重要。Objective To investigate the detection of treponema pallidum(TP)antibodies of patients in outpatient and inpatient clinics and the false positive samples screened by chemiluminescence microparticle immunoassay(CMIA)to evaluate the application value of CMIA in anti-TP detection.Methods CMIA was used to screen 44558 clinical specimens for TP-specific antibodies in the outpatient and inpatient clinics of Beijing Jiangong Hospital from January 2017 to December 2019.The positive samples of anti-TP were furtherly confirmed by the Treponema pallidum particle agglutination test(TPPA)and rapid plasma reagin ringing card test(RPR)detection,the results of anti-TP screening,RPR titer and the analysis of different age stages and gender groups were statistically analyzed by SPSS 25.0,respectively.Results Total of 44558 serum samples were screened for anti-TP by CMIA,and 996 samples with positive anti-TP were detected.And 898 positive samples were confirmed by TPPA.Compared with the positive results confirmed by CMIA and TPPA,the false positive rate was 0.22%(98/44558),the positive predictive value was 90.16%(898/996),and the specificity was 99.78%(43660/43758).For samples with S/CO values greater than 9,the positive predictive value of TPPA confirmed was 100.00%(898/898),and the S/CO value was divided into 5 groups of 1-2,2-3,3-5,5-9 and>9,and TPPA positive predictive value difference was statistically significant(χ^(2)=309.81,P<0.001).Among the 996 RPR detected samples,336 cases were positive for RPR,and samples with titers≤1︰8 accounted for 84.23%(283/336)of the positive samples for RPR.The positive rate of≥80 years old group was the highest.The positive rate of positive samples confirmed by TPPA was 2.76%(84/3042),which was higher than the overall positive rate of 2.02%(898/44558),with significant difference(χ^(2)=7.84,P=0.005).The positive detection rate confirmed by TPPA for males was 2.68%(467/17413),which was 1.59%(431/27145)for females,with significant difference(χ^(2)=64.31,P<0.001).The 40-59 years old group

关 键 词：梅毒螺旋体抗体 化学发光微粒子免疫分析法 梅毒螺旋体颗粒凝集试验 快速血浆反应素环状卡片试验 

分 类 号：R446.6[医药卫生—诊断学] R759.1[医药卫生—临床医学]